Manufacturing Site Requirements for Drug Registration in the UAE
Manufacturing Site Requirements for Drug Registration in the UAE
When registering a drug in the United Arab Emirates (UAE), one of the key aspects evaluated by the Ministry of Health and Prevention (MOHAP) is the manufacturing site where the drug is produced. The UAE places strict quality assurance standards to ensure that all imported or locally manufactured pharmaceutical products meet international safety and efficacy guidelines.
Below are the key requirements and considerations for the manufacturing site in the drug registration process:
1. Good Manufacturing Practice (GMP) Certification
The manufacturing site must hold a valid GMP certificate issued by the health authority of the country of origin or recognized international regulatory bodies (e.g., FDA, EMA, TGA, WHO).
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GMP certification should be current and cover the specific product forms (e.g., tablets, syrups, injectables).
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MOHAP may request an on-site inspection if GMP compliance is in doubt or if the facility is not previously registered.
2. Certificate of Pharmaceutical Product (CPP)
A Certificate of Pharmaceutical Product (CPP) must be submitted, confirming that:
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The product is approved for sale in the country of origin.
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It is manufactured in a GMP-compliant facility.
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The same product formulation is intended for the UAE market.
The CPP must be issued by the competent authority of the country where the manufacturing site is located.
3. Manufacturing Site Registration
Before any product registration, the manufacturing site itself must be registered with MOHAP. This includes:
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Full address and contact details of the facility
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Licensing and GMP certification documents
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List of products manufactured at the site
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Technical overview of manufacturing operations and quality control
4. Site Master File (SMF)
The manufacturer must provide a Site Master File that includes:
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Organizational structure
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Quality assurance systems
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Equipment and facilities
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Personnel qualifications
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Sanitation and hygiene measures
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Documentation practices
This file should follow WHO or EU SMF guidelines.
5. Multiple Manufacturing Sites
If a product is manufactured at more than one site (e.g., one for formulation and another for packaging), each site must be declared and registered. Each must provide:
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GMP certification
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Description of roles and responsibilities
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Clear documentation showing the manufacturing chain
6. MOHAP Inspections (if required)
MOHAP reserves the right to:
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Conduct its own inspection of the manufacturing site
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Request clarifications or corrective actions
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Suspend or reject registration if quality compliance is not met
Conclusion
Registering a drug in the UAE is not just about the product itself—it requires transparency and verification of the manufacturing process and facility. Ensuring your manufacturing site complies with GMP standards, is properly licensed and registered, and provides the required technical documentation is essential to gaining regulatory approval from MOHAP.
For pharmaceutical companies looking to enter the UAE market, early preparation of manufacturing site documents can significantly reduce delays in the registration process.
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